Daytime Nighttime Cold Flu Relief

Product NDC
49035-192
11-digit product format
490350192
Labeler code
49035
Product ID
49035-192_89cec16a-3fb8-4d83-8bae-a53d7ef6ce38
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCL
Dosage form
KIT
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-30
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Daytime Nighttime Cold Flu Relief
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup
1094549Internal RxNorm lookup
2634564Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f288eeca-9803-4962-a802-fe34f5983c7aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-192-48Daytime Nighttime Cold Flu Relief1 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-192DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]3Current NDC, Legacy NDC, 1 package rows20240322_f288eeca-9803-4962-a802-fe34f5983c7a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 129 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC5372f764-985e-4a42-bc97-cb0dc90fcd9c2024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTOPCO ASSOCIATES LLC5a2d0464-038d-4c3f-b39e-ee9984fb383e2024-12-18WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINValu Mercha72b6a97-f97f-44bb-8d55-ac48b8ba45c52024-12-18WarningsExact identifier
application number: M012
Harris Teeter Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter4ebe1d94-bb15-4250-a4c2-8cd45743c7dd2024-12-18WarningsExact identifier
application number: M012
Care One Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRETAIL BUSINESS SERVICES , LLCf6657dee-9f32-45b1-8e44-1ad67a4a68bd2024-12-18WarningsExact identifier
application number: M012
Childrens Metapp DaytimeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLGuardian Drug Company40565500-944b-47f2-8563-5df05469e4182024-12-18WarningsExact identifier
application number: M012
CVS Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCVS Pharmacy, Inc.884abed2-e355-4134-92f1-591f3a18f71d2024-12-18WarningsExact identifier
application number: M012
CVS Health Chest Congestion Relief PEGUAIFENESIN/PHENYLEPHRINECVS Pharmacy, Inc.a49020e8-739e-47ec-8141-e866479a3ab32024-12-18WarningsExact identifier
application number: M012
Family Wellness Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINFamily Dollar Services Inc8aee8108-a4e0-4956-8e37-6b3b1c5dc6832024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion ReliefGUAIFENESINTOPCO ASSOCIATES LLCb8339617-17ce-4ad7-af38-399ecc74d8642024-12-18WarningsExact identifier
application number: M012
Kroger Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETHE KROGER CO976bfdcf-2110-486c-aa6e-cd2067334cdc2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINAmerisourceBergen Drug Corp79cefd46-bd19-4a1d-9cb1-e85ff0f124942024-12-18WarningsExact identifier
application number: M012
Leader Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCardinal Health8397e1b9-e83e-4c6a-b858-1663c23658402024-12-18WarningsExact identifier
application number: M012
GNP Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEAmerisourceBergen Drug Corp63932e68-b09d-4500-bc1d-cfb2c267df1c2024-12-18WarningsExact identifier
application number: M012
Meijer Chest Congestion ReliefGUAIFENESINMeijer Distribution Inc.ae02e0bd-d9e7-495f-b01f-b135b96934a02024-12-18WarningsExact identifier
application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PEGUAIFENESIN/PHENYLEPHRINETOPCO ASSOCIATES LLCb6c0362f-86ca-4f08-ba53-800c6df2c0252024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC10cad9a7-1223-470c-9027-807891217d402024-12-18WarningsExact identifier
application number: M012
Kroger Mucus ReliefGUAIFENESINTHE KROGER CO2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e2024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Association41f88b43-3e0a-4650-b167-a72afe6177e82024-12-18WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRugby Laboratories5da36516-9f94-49cb-9421-0c310abcd1162024-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKf288eeca-9803-4962-a802-fe34f5983c7a5
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNf288eeca-9803-4962-a802-fe34f5983c7a5
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNf288eeca-9803-4962-a802-fe34f5983c7a5
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNf288eeca-9803-4962-a802-fe34f5983c7a5
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDf288eeca-9803-4962-a802-fe34f5983c7a5
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDf288eeca-9803-4962-a802-fe34f5983c7a5
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYf288eeca-9803-4962-a802-fe34f5983c7a5
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYf288eeca-9803-4962-a802-fe34f5983c7a5
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYf288eeca-9803-4962-a802-fe34f5983c7a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-192-48490350192481 KIT in 1 KIT (49035-192-48) * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK1 kit2020-01-300000-00-00NoNoCurrent